On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.  The committee voted almost unanimously to move the bipartisan bill forward, with only Senator Bernie Sanders (I-Vt.) and Senator Rand Paul (R-Ky.) voting against it.  And in an interesting overlap of FDA-related news, the Agency’s brand-new Commissioner, Dr. Scott Gottlieb, was also sworn in on May 11th following a speedy (albeit politically controversial and party-line) confirmation process and Senate vote.  With less than a week on the job, Dr. Gottlieb is already receiving pressure from varied stakeholders to ensure the user fee legislation is enacted in a timely manner in order to avoid disrupting the Agency’s work. Continue Reading FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.  As we previously reported, a discussion draft of the FDA Reauthorization Act was released jointly by leaders of the Senate HELP Committee and the House Energy & Commerce Committee two weeks prior to that comment deadline.  It now seems that the late start to the 2017 user fee legislative process – along with the rapid approach of summer and the risk of Agency layoffs if this five-year reauthorization cycle is not completed before August – has gotten everyone pushing on the accelerator a bit. Continue Reading More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting (see here and here for our past coverage), these two committees have held numerous public hearings since the beginning of March to learn more about FDA’s “big 4” user fee programs – for prescription drugs, medical devices, generic drugs, and biosimilars.  Continue Reading Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C) Subcommittee on Health.  That hearing focused on the UFAs specific to generic drugs and biosimilar biological products.  Since then, Congress has held several more UFA hearings, and multiple FDA-related bipartisan bills that could become important to this process have been introduced.  So it’s time for an update on how things are going with the UFA reauthorizations. Continue Reading FDA User Fee Hearings Picking Up Steam on Capitol Hill

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining the state of competition in the pharmacy and PBM marketplace.  You can watch the hearing and read the filed testimony here. This was the third in a series of congressional hearings examining competition in healthcare markets. While the focus was on PBMs and pharmacies, some panelists and committee members recognized that a full discussion of certain issues, like drug pricing, needs to involve other players in the prescription drug supply chain.

The witness panel included 2 PBM industry representatives, an independent pharmacy owner, and an antitrust attorney who represents the interests of independent pharmacies:

  • Amy Bricker, Vice President of Retail Contracting & Strategy, Express Scripts
  • Natalie A. Pons, Senior Vice President and Assistant General Counsel, CVS Health
  • Bradley J. Arthur, Owner, Black Rock Pharmacy
  • David A. Balto, Law Offices of David Balto

Each panelist gave testimony aligned with his or her role in the debate and voiced well entrenched opinions regarding the role PBMs play in the health care industry. Ms. Bricker and Ms. Pons each focused on their PBM’s ability to use scale to keep prescription drug costs down for patients and their clients, and stressed that they rely on independent pharmacies to participate in their networks. Mr. Arthur focused on the scale of the PBMs compared to his independent pharmacy, while Mr. Balto pointed to market trends, like rising profit margins, to claim that the entire PBM marketplace is broken and needs regulation to require more transparency. Continue Reading Congressional Hearing Examines Competition in the PBM Industry